The Recall Desk

Hazard

Class I recalls

702 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
702
Critical
345
Severe
343
Most recent
2026-07-31

Of the 702 class i recalls we have scored against our rubric, 345 (49%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 343 (49%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all class i recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

451–475 of 702

  • CriticalFDA (Food)·H-0605-2025·2025-09-24

    Honey balsamic dressing pouches recalled over undeclared soy and sesame

    Honey Balsamic dressing in 3.4 ounce plastic pouches is recalled because it contains undeclared soy and sesame. The FDA classified the action as Class I. 46,800 units are affected.

    Product
    Honey Balsamic dressing, 3.4 ounce plastic pouch, Best by date and Lot number appear directly on pouch.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-2539-2025·2025-09-24

    SmartDrive MX2-3DCK dials recalled over faulty connection to wheelchair motor

    SmartDrive MX2+ SpeedControl Dials, REF MX2-3DCK, are recalled because a faulty electrical connection between the dial and the wheelchair motor may cause loss of control. 15,834 units are affected.

    Product
    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
    Category
    Medical Device
    Distribution
    52 states
  • CriticalFDA (Food)·H-0617-2025·2025-09-24

    Frozen mixed vegetables recalled over possible Listeria monocytogenes contamination

    Endico brand Mixed Vegetables, 2.5 lb frozen bags produced 06/17/2025, are recalled because the product may be contaminated with Listeria monocytogenes. The FDA classified the action as Class I.

    Product
    Endico brand MIXED VEGETABLES; NET WT. 2.5 lbs (40 oz.) (1134 g); KEEP FROZEN UNTIL READY TO USE; Dist. by Endico Potatoes Inc; PRODUCT OF EGYPT; To prepare: Place contents in boiling water. Cook until tender. Season to taste and serve.; Cook to 165 F For Quality And Food…
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·H-0614-2025·2025-09-24

    Piccolo Pranzo boxes recalled over undeclared wheat and milk allergens

    Piccolo Pranzo Box, 14.5 oz, from Fresh and Ready Foods is recalled for undeclared wheat and milk. The FDA classified the action as Class I. 233 units are affected.

    Product
    Piccolo Pranzo Box; Keep Refrigerated, NET WT: 14.5 OZ, UPC# Manufactured by Fresh and Ready Foods LLC, San Fernando, CA 91340
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0655-2025·2025-09-24

    Cyclobenzaprine bottles recalled after being filled with meloxicam tablets instead

    Unichem Cyclobenzaprine Hydrochloride Tablets, 10 mg, lot GMML24026A, are recalled because bottles labeled as cyclobenzaprine contained yellow Meloxicam 7.5 mg tablets. The FDA classified the action as Class I.

    Product
    CYCLOBENZAPRINE HYDROCHLORIDE — CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2483-2025·2025-09-24

    Blood and fluid warming sets recalled to clarify flow rates and temperatures

    3M Ranger Blood/Fluid Warming High Flow Sets are the subject of a field action to clarify flow rates, inlet fluid temperatures and the location of the outlet temperature. The FDA classified it as Class I.

    Product
    3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2484-2025·2025-09-17

    Aspiration biopsy needles recalled over undetected deformed atraumatic tips

    ViziShot 2 FLEX single use aspiration needles, model NA-U403SX-4019, are recalled because of the potential for undetected, deformed atraumatic tips. The FDA classified the action as Class I. 104,508 units are affected.

    Product
    ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0572-2025·2025-09-17

    Caramel apple pecan topped brie recalled over possible Listeria contamination

    Wegmans Caramel Apple Pecan Topped Brie Cheese, small 13 oz, is recalled because it may be contaminated with Listeria monocytogenes. The FDA classified the action as Class I.

    Product
    Wegmans Caramel Apple Pecan Topped Brie Cheese -Small - 13 OZ - Clear plastic container with lid UPC: 2-77645-XXXXX-3 (X - varies by weighted price)
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·H-0570-2025·2025-09-17

    Assorted cheese flight recalled over possible Listeria monocytogenes contamination

    Wegmans Assorted Cheese Flight, sold by the pound, is recalled because it may be contaminated with Listeria monocytogenes. The FDA classified the action as Class I.

    Product
    Wegmans Assorted Cheese Flight - Varies (sold by the lb) - Black Plastic container with clear lid UPC: 2-77100-XXXXX-5 (X - varies by weighted price)
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·H-0569-2025·2025-09-17

    Camembert soft ripened cheese recalled over possible Listeria monocytogenes contamination

    Wegmans Medium Camembert Soft Ripened Cheese, 8.8 oz, is recalled because it may be contaminated with Listeria monocytogenes. The FDA classified the action as Class I.

    Product
    Wegmans Medium Camembert Soft Ripened Cheese - 8.8oz - Round wooded container; UPC: 2-77467-00000-7 , 0-77890-53515-8
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·H-0571-2025·2025-09-17

    Grilling camembert with tapenade recalled over possible Listeria monocytogenes contamination

    Wegmans Grilling Camembert with Tapenade & Roasted Tomatoes, 10 oz, is recalled because it may be contaminated with Listeria monocytogenes. The FDA classified the action as Class I.

    Product
    Wegmans Grilling Camembert with Tapenade & Roasted Tomatoes - 10 OZ - Overwrapped black and gold metal tray UPC: 2-77297-XXXXX-0 (X - varies by weighted price)
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Drugs)·D-0611-2025·2025-09-10

    External analgesic lotion recalled over Burkholderia cepacia contamination

    DermaSarra External Analgesic containing camphor 0.5%, lot 40187.2, is recalled because the product was found contaminated with Burkholderia cepacia. The FDA classified the action as Class I.

    Product
    DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2436-2025·2025-09-10

    TruSteer transseptal access systems recalled over higher air embolism risk

    Boston Scientific is recalling WATCHMAN TruSteer Access Systems after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.

    Product
    WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2333-2025·2025-09-10

    Syringe pumps recalled over false motor movement system error messages

    Baxter is issuing an urgent correction for Novum IQ Syringe Pumps, product code 40800BAXUS, over software anomalies causing a blank Run screen or a false motor movement system error. 10,101 units are affected.

    Product
    Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-2431-2025·2025-09-10

    WATCHMAN TruSeal access systems recalled over air embolism during transseptal access

    Boston Scientific is recalling WATCHMAN TruSeal Access System SGL, US, after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.

    Product
    WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0628-2025·2025-09-10

    Sodium chloride injection containers recalled over presence of particulate matter

    B. Braun 0.9% Sodium Chloride Injection USP in 1000 mL containers, lot V3K770, is recalled for the presence of particulate matter. The FDA classified the action as Class I. 47,148 containers are affected.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0616-2025·2025-09-10

    Honey balsamic salad kits recalled over undeclared sesame and soy allergens

    Taylor Farms Honey Balsamic Salad Kits, 8.3 oz, are recalled for undeclared sesame and soy. The FDA classified the action as Class I. 8,284 cases are affected.

    Product
    Salad Kit labeled as follows: Taylor FARMS Honey Balsamic SALAD KIT, NET WT. 8.3 OZ (235g), INGREDIENTS: HONEY BALSAMIC VINAIGRETTE (soybean oil ...) SPINACH, CARROT, SEA SALT CROISSANT CROUTON (wheat flour ...) CRUMBLED FETA CHEESE (feta cheese [pasteurized milk ...] ...)…
    Category
    Food
    Distribution
    18 states
  • CriticalFDA (Devices)·Z-2448-2025·2025-09-10

    Dexcom G7 watchOS app recalled because sensor failure alerts are missing

    The Dexcom G7 CGM watchOS App, versions 2.8.0 and earlier, is recalled because it does not give the expected Sensor Failed alert and silently ends the session. 907,842 units are affected.

    Product
    Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: versions 2.8.0 and earlier Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2480-2025·2025-09-10

    Left heart vent catheters 13FR recalled because they may not retain shape

    DLP Left Heart Vent Catheters, model 12113, are recalled because the catheters may not retain their shape. The FDA classified the action as Class I. 34,549 units are affected.

    Product
    DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2482-2025·2025-09-10

    Left heart vent catheters recalled because they may not retain shape

    DLP Left Heart Vent Catheters, model 12115, are recalled because the catheters may not retain their shape. The FDA classified the action as Class I. 25,261 units are affected.

    Product
    DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2454-2025·2025-09-10

    Wheelchair joysticks recalled over unintended movement on power-up

    Micro Joystick R-net wheelchair controls with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 3 units are affected.

    Product
    Micro Joystick R-net. Electrical wheelchair component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2457-2025·2025-09-10

    IDM-MULTI-R wheelchair controls recalled over unintended movement at power-up

    IDM-MULTI-R wheelchair components with firmware 2.3 or lower are recalled because timing variations may skip the neutral check, producing unintended movement on power-up. 15 units are affected.

    Product
    IDM-MULTI-R. Electrical wheelchair component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2435-2025·2025-09-10

    FXD Curve double access systems recalled over transseptal air embolism risk

    Boston Scientific is recalling WATCHMAN FXD Curve Access System Dbl after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.

    Product
    WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-2334-2025·2025-09-10

    Novum IQ syringe pumps recalled over software anomalies affecting the run screen

    Baxter is issuing an urgent correction for Novum IQ Syringe Pumps, product code 40700BAX, over software anomalies that may cause a blank Run screen or a false motor movement system error. 22,703 units are affected.

    Product
    Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-2432-2025·2025-09-10

    TruSeal DBL access systems recalled over air embolism risk without ventilation

    Boston Scientific is recalling WATCHMAN TruSeal Access System DBL, US, after identifying a higher likelihood of air embolism when procedures are performed without positive pressure-controlled ventilation.

    Product
    WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states